Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

Tipranavir(TPV)/Low Dose Ritonavir(r)

No text entered.

Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

No text entered.

Total

Total of all reporting groups

Baseline Measures

Tipranavir(TPV)/Low Dose Ritonavir(r)

Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

Total

Number of Participants
[units: participants]

435

428

863

Age
[1][units: years]Mean (Standard Deviation)

42.5
(8.4)

42.9
(8)

42.7
(8.2)

Gender
[1][units: participants]

Female

84

64

148

Male

351

364

715

[1]

3 patients were not randomized but treated with TPV/r. They are included in the participant flow and adverse events but not in the efficacy analysis.

Time to treatment failure is defined as 0 for patients who never achieve TR otherwise time to treatment failure is the earliest time of death, discontinuation of the study drug or introduction of a new anti-retroviral drug to the regimen if it is not solely related to either toxicity or intolerance clearly attributable to a background, or the first of two consecutive visits with Log(baseline Viral Load) - Log(on-treatment Viral Load) < 1.

Time Frame

after 96 weeks of treatment

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Full Analysis Set (FAS), included all randomized patients treated with at least one dose of study medication

Reporting Groups

Description

Tipranavir(TPV)/Low Dose Ritonavir(r)

No text entered.

Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

No text entered.

Measured Values

Tipranavir(TPV)/Low Dose Ritonavir(r)

Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)

Number of Participants Analyzed
[units: participants]

435

428

Time to Treatment Failure Through 96 Weeks of Treatment
[units: Days]Median (Inter-Quartile Range)

115
(0 to 811)

0
(0 to 112)

Statistical Analysis 1 for Time to Treatment Failure Through 96 Weeks of Treatment

Groups [1]

All groups

Method [2]

Log Rank

P Value [3]

0.0001

[1]

Additional details about the analysis, such as null hypothesis and power calculation:

No text entered.

[2]

Other relevant method information, such as adjustments or degrees of freedom:

No text entered.

[3]

Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:

No text entered.

17. Secondary:

Time to Confirmed Virologic Failure Through 48 Weeks of Treatment [ Time Frame: after 48 weeks of treatment ]